This study is a prospective, single-arm, multicenter trial designed to evaluate the hematologic response rate and safety of GPRC5D/CD3 bispecific antibody bridging therapy prior to CAR-T cell infusion in patients with relapsed/refractory multiple myeloma (RRMM).
Voluntary Participation: Ability to understand and voluntarily sign the informed consent form (ICF).
Age ≥18 years.
Confirmed symptomatic MM diagnosis per the Chinese Guidelines for Diagnosis and Management of Multiple Myeloma (2022 Revision).
Successful apheresis for CAR-T cell manufacturing.
Prior GPRC5D-targeted immunotherapy.
Investigator-assessed contraindications to GPRC5D×CD3 bispecific antibody therapy (e.g., severe cardiopulmonary diseases incompatible with treatment).
Grade >2 peripheral neuropathy or ≥grade 2 painful neuropathy at screening (regardless of current medication).
Known intolerance, hypersensitivity, or contraindication to GPRC5D×CD3 bispecific antibody components.
Single group
QLS32015
Biological/VaccineQLS32015 is a GPRC5D × CD3 bispecific antibody.
Overall Response Rate (ORR)
The proportion of subjects achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) after treatment with QLS32015 injection
Safety and Tolerability
The incidence of treatment-emergent adverse events (TEAES)
Time to Response (TTR)
Time from first BCMA×CD3 bispecific antibody infusion to first hematologic response，Depth of best hematologic response: The highest-level response achieved at any timepoint
Duration of Response (DOR)
Duration of response (DOR) was defined as the time from first documented hematologic response (≥ partial response \[PR\]) to disease progression or death due to progression, whichever occurred first
Overall Survival (OS)
Progression-Free Survival (PFS)
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
